Hybrid SystemTM

Surgical Technique Manual

For Anterior Cruciate Ligament Reconstruction

0086

Hybrid SystemTMIntroduction

The Hybrid System comprises a set of fixation devices that allow the construction of a “Hybrid graft” for the anatomical reconstruction of a ruptured Anterior Cruciate Ligament (ACL). It has the following advantages:• thesurgeoncancontrolthethicknessandlengthof

the autograft1,2, which also allows short length grafts to be adapted for use in ACL reconstruction3;

• thestructuralpropertiesaresuperiortothosewheresutures are used and are comparable to the Bone-Tendon-Bone (BTB) graft4,5;

• itismoreresistanttografttensionrelaxationthanwhen using sutures for fixation6;

• whenusingadouble-bundleanatomictechniquethetwo grafts can be easily and simultaneously fixed1;

• itisparticularlysuitedtomultipleligamentinjuries.

WewouldliketothankProfessor Kazunori Yasuda, M.D. PhD., and Dr Eiji Kondo, M.D. PhD., Department of SportsMedicineandJointSurgery,HokkaidoUniversitySchoolofMedicine,Sapporo,Japan,fortheirworkindevelopingthisproductandtechnique.

LK2-H

FlexibilityALTERNATIVE TECHNIQUES AND FIXATION DEVICESThe Hybrid System offers flexibility in ACL reconstruction bythewayofsurgicaltechnique,graftselectionandconstruction, and graft anchoring to the bone. It offers:• anatomicsingle-bundleoranatomicdouble-bundlesurgicaltechniques:Theanatomicdouble-bundleprocedure is superior to the single-bundle procedure in terms of restoration of the anterior stability and rotationalkneestabilityinbothbiomechanical6 and clinical studies7;

• varietyingraftselection:Thesecanbeformedfromthe semitendinosus and/or the gracilis hamstring tendons;

• varietyingraftconstruction:Thesecanbeformedbylooped or folded tendons;

• femoralfixation:ThisisprovidedbytheLK2-H(Neoligaments). It can also be achieved with the EndoButtonCLUltraorEndoButtonCLBTB (Smith & Nephew)8;

• tibialfixation:Thisisachievedwitha10mmPoly-Tape(Neoligaments)andtwogenericsmallspikedstaples.Alternatively,asingleFastlokTM (Neoligaments) can be used for anatomic single tunnel tibial fixation.

INDICATIONThe Hybrid System is a group of single use implants intended to be used for ACL reconstruction.

Contraindications to surgery include:• infectionsoranystructuralorpathologicalcondition

of the bone or soft tissue that would be expected to impair healing or secure fixation;

• thepatient’sinabilityorunwillingnesstorestrictactivities to prescribed levels or follow the rehabilitation programme during the healing period.

Anatomic single tunnel•Transtibialapproach•6strandgraft(8-11mmdia)

Anatomic double tunnel•Transtibialapproach•AMB(anteromedialbundle):2or4strandgraft(6-8mmdia)•PLB(posterolateralbundle):2strandgraft(6mmdia)

Femoral fixation can also be achieved with the EndoButton CLUltraorEndoButtonCLBTB(Smith & Nephew)

Femoral fixation can also be achieved with the EndoButton CLUltraorEndoButtonCLBTB(Smith & Nephew)

LK2-H(Neoligaments)

Tendon

Poly-Tape

DoublespikedstapleorFastlok

Doublespikedstaple

Product Overview

IMPLANTSThe Hybrid System uses a 10 x 500 mm Poly-Tape in conjunctionwitha6mmFastlokfixationdeviceor2genericsmallspikedstaplesfortibialfixation.FemoralfixationisprovidedbyanLK2-H,ortheEndoButtonCLUltraorEndoButtonCLBTB,whichmaybesourcedfromSmith & Nephew.

INSTRUMENTATIONThe Hybrid graft can be implanted using modern ACL guidewire systems that are utilized for hamstring grafts. Please note that these instruments are not provided and should be sourced by the surgeon prior to performing the operation.

IfutilizingtheFastlokforfixationwiththeanatomicsingletunneltechnique,theusercanalsoorderthefollowingstandard items:• Fastlokimpactor/extractor;• Fastlokslidinghammer.

NOTE:TheLK2-HisnotavailableforsaleintheUnitedStates.

10mm Poly-Tape

LK2-HTitanium alloy SurfButton

Fastlok

Buckle Staple

FEATURES & BENEFITSTheLK2-Hcomprisesa10x500mmPoly-Tapeandatitanium alloy SurfButton. It therefore provides all the advantages of the Poly-Tape (as described below) while also having several additional structural features intended to facilitate the surgery and improve its outcome:• thetransverseyarnsareremovedtoprovideparallel

fibres where the Poly-Tape is threaded through the SurfButton. This facilitates a low profile when the button is seated on the lateral femoral cortex;

• theLK2-Hcanbeattachedtoaclosedloopoftendonwhich allows the reconstruction of the Hybrid graft to occur concurrently with the preparation of the bone tunnels and so minimizes the operating time;

• continuouslongitudinalyarnsprovideahighstrengthto allow early mobilization.

The Poly-Tape is a flexible textile device, which has the following general advantages:• itismanufacturedfrompolyester,abiocompatible

material that has been in use for the reconstruction of ligaments and tendons for over 25 years;

• theflat,openweavesectionofthePoly-Tapeactsasascaffold that encourages tissue ingrowth.

The Poly-Tape also has the following advantages over sutures used for fixation of ACL grafts:• thewidetapedoesnotcutthroughthegrafttissue;• itsmeshstructureprovidesgoodgripwiththestapleorFastloksoreducingslippagepastthestapleorFastlok;

• thereisareducedchanceofcuttingthemeshcompared to sutures when impacting the staple or Fastlok.

TheFastlokismadefromtitaniumalloyandconsistsofastapleandbuckle.Ithasseveralstructuralfeaturesintended to facilitate the surgery and improve its outcome:• thebuckleprovidesauniquetripleclampingactionto

minimize slippage under repeated loading;• thebridgeofthestapleisshapedtoallowthe

instrumentation to be securely clamped, so it is easy to implant and remove.

ANATOMIC DOUBLE-BUNDLE PROCEDURESincetheprocedureforACLreconstructioniswellknown,the following text is primarily concerned with the ways in which the Hybrid System differs from a standard ACL technique.

Patient Preparation The procedure is performed with the patient in the supine position with the femur horizontal and the tibia flexed at 90º,inthe“Hanginglegposition”.Thisopensthekneejointduringsurgeryduetogravityandthetibiaiseasilypositioned at 90º. This position also enables the femoral PL bundle to be easily recognized.

ApproachStandard medial and lateral infrapatellar portals are established together with a 3 cm long transverse incision in the anteromedial aspect of the proximal tibia. An arthroscope is inserted through the lateral infrapatellar portal. The ACL remnant is resected, leaving a 1 mm long ligament stump at the femoral and tibial insertions to obtainlandmarksforinsertingguidewires.Notchplastyis performed in chronic cases when an osteophyte has formed at the notch.

Graft harvesting and preparationThe leg is flexed to approximately 100º with the lateral surface of the leg lying on the table. A semitendinosus (ST)tendonisharvestedusingstandardtechniquesandinstruments (not provided). When this tendon is longer than24cmandwhendoubledisthickerthan6mm,thefollowing preparation is used.

The ST tendon is transversely cut in half.

To form the anteromedial (AM) bundle, the distal half of the ST tendon is doubled over to produce a loop. Both the free ends are firmly sutured side by side at 3 different positions,usingthecircumferentialligationtechnique(seestep 3) with No 2-0 polyester suture.

NOTE:IfusingtheEndoButtonCLUltra,thisdeviceneedstobelinkedtothetendonloopbeforetheendsofthetendon are sutured. Its length is matched to the femoral tunnel measured during surgery.

To form the posterolateral (PL) bundle, the proximal half of the ST tendon is doubled, and the ends secured using the samecircumferentialligationtechnique.

Alternative graft harvesting and preparationWhen the ST is short or thin, the gracilis (GR) tendon is also harvested.

TheSTtendonistransverselycutinhalf.Thethickestportion of the GR tendon is resected so that the length is matched to one half of the ST tendon.

To form the anteromedial (AM) bundle, one half of the ST tendon and the resected GR tendon are doubled over to produce a loop. Both the free ends are firmly sutured side by side at 3 different positions, using the circumferential ligationtechnique(seestep3)withNo2-0polyestersuture.

NOTE:IfusingtheEndoButtonCLUltra,thisdeviceneedstobelinkedtothetendonloopbeforetheendsof the tendon are sutured. Its length is matched to the femoral tunnel measured during surgery.

To form the posterolateral (PL) bundle, the remaining half of the ST tendon is doubled, and the ends secured using thesamecircumferentialligationtechnique.

Surgical Technique

1 2

Semitendinosus tendon (ST)

Cut

For AM Bundle

Loop 1/2 distal ST

For PL Bundle

Loop 1/2 proximal ST

Semitendinosus tendon (ST)

Gracilis tendon (GR)

Cut

For AM Bundle

Loop 1/2 STLoop 1/2 GR

For PL Bundle

Loop 1/2 ST

Circumferential ligationtechniquein3positions

Circumferential ligationtechniquein3positions

Circumferential ligation techniqueA. A polyester No 2-0 suture is passed through the tendonendsusingastandardtechnique.Theendsofthesutureareknotted.

B. The same suture is wrapped around the tendon ends.C. The ends of the suture are tensioned to pull the suture

tight around the tendon ends.D. Theendsofthesutureareknottedtofirmlysecure

the tendon ends side by side and excess suture is trimmed.

By means of a guide, in a Japanese patient series using thealternativegraftharvestingandpreparationtechniquedescribed in point 2, the autogenous tendon portion of the graft ranged from 55 to 65 mm. The intra-articular portion of the AM bundle graft was 30 to 35 mm, and that of the PL bundle graft was 25 to 30 mm. The minimum length of the graft placed within the tunnel was 15 to 20 mm9.

Creation of the Hybrid graftA Hybrid graft for the AM bundle is constructed. A 10 x 500 mm Poly-Tape is passed through the tendon loop and placed at the sutured end. The tape is firmly sutured to thetendonusingacircumferentialligationtechniquein3positions. This tape will be used for tibial fixation.

The femoral component of the Hybrid graft is created after the femoral bone tunnel is drilled and its length measured so that the corresponding length of the fixation device is thereby determined.

WhenusingtheLK2-Hforfemoralfixation,bothendsofthetapecomponentoftheLK2-Hdevicearepassedthrough the opposite end of the tendon loop. The tape ends are sutured side-by-side using the circumferential ligationtechniquein3positions.

A Hybrid graft for the PL bundle is constructed in the same manner as the AM bundle.

3 4 5

HybridgraftusingtheLK2-H(AMBundleshown): HybridgraftusingtheLK2-H(Neoligaments):

AM Bundle : 4 strands(Doubled 1/2 ST+GR, typical dia. 6 - 8 mm, 55 to 60 mm in length)

PL Bundle : 2 strands(Doubled 1/2 ST, typical dia. 6 mm, 45 to 50 mm in length)

2absorbablesuturesareusedasmarkerstoaidflipping the button (15mm of graft in tunnels)

Tape ends are sutured side-by-side using thecircumferentialligationtechniquein3positions

LK2-H

Poly-Tape

C D

A B

When using the EndoButton CL BTB for femoral fixation, the long CL loop of the device is passed through the tendon loop and then through the short CL loop. The long loop is then slipped over the EndoButton and the resulting knottightened.

AM Bundle

PL Bundle

PL tibial tunnelAn appropriate tibial guide (not supplied) is used to create the two bone tunnels in the tibia.

First a tibial tunnel for the PL bundle is created. The aimerportionoftheguideisintroducedintothejointcavitythroughthemedialinfrapatellarportal.Thekneeisflexedat90ºkeepingthefemurhorizontal(“Hangingleg position”). The tip of the aimer is placed at the centre of the PL bundle footprint on the tibia. This is located at the most posterior aspect of the area between the tibial eminences and 6 to 7 mm anterior to the posterior cruciateligament(the“overthebackridge”distance).Thebullet of the guide is fixed on the anteromedial aspect of the tibia at approximately 45º from vertical and 5 to 10 mm anterior to the medial collateral ligament10. A guidewire is drilled into the tibia.

The tibial tunnel is made with a cannulated drill corresponding to the measured diameter of the prepared PL Hybrid graft.

AM tibial tunnelThe tibial aimer of the guide is placed at the centre of the tibial footprint of the AM bundle. This is located at a point approximately 8 mm anterior to the guidewire for the PL bundle and 5 mm lateral from the medial tibial spine. The bullet of the guide is fixed on the anteromedial aspect of the tibia at approximately 20º from vertical which is approximately 20 mm medial to the centre of the PL tunnel10.

Thekneeisextendedtoensurethetipoftheguidewireislocated at the point 5 mm posterior to the anterior edge of the roof in the intercondylar notch.

A guidewire is drilled in the tibia. The tibial tunnel is made with a cannulated drill corresponding to the measured diameter of the prepared AM Hybrid graft.

6 78

PCL

Overthebackridge

PL Tunnel(dia. 6 mm)

AM Tunnel(dia. 6-8 mm)

6-7 mm

8 mm

5 mm

Hybrid graft using the EndoButton CL BTB (Smith & Nephew):Lateral infrapatellar portal

Medialinfrapatellar portal

3 cm long transverse incision in the anteromedial aspect of the proximal tibia

PL Tunnel(dia. 6 mm)

45˚

20˚

AM Tunnel(dia. 6-8 mm)

AM femoral tunnelThe arthroscope is located in the lateral infrapatellar portal. A standard transtibial offset femoral ACL drill guide (not supplied) is used to locate the tunnel at the most appropriate point on the femur.

A guidewire is drilled at the centre of the femoral footprint of the AM bundle through the second (AM) tibial tunnel, using a standard transtibial offset femoral ACL drill guide. The offset guide is typically 5 mm or 6 mm. The guide is orientatedinthe10:30o’clock(rightknee)or1:30o’clock(leftknee)position.Theguidewireisover-drilledwitha4.5mm diameter cannulated bone tunnel drill, through the lateral cortex. The length of the tunnel is measured with a depth gauge.

The construction of the AM Hybrid graft is completed by settingtheLK2-Htothecorrectlengthandsecuringitwithsutures (shown in Figures 4 and 5). Alternatively, the correct length of EndoButton CL BTB is chosen (shown in Figure 6).

PL femoral tunnelThe arthroscope is moved to the medial infrapatellar portal as it is difficult to precisely identify the attachment of the PL bundle through the lateral infrapatellar portal. The tibiaisheldat90ºofkneeflexion,keepingtheaxisofthefemoral shaft (AFS) horizontal (“Hanging leg position”).

A guidewire is drilled at the centre of the PL bundle attachment on the femur through the first (PL) tibial tunnel. A zero offset aimer is used or the guidewire is manually aimed. If manually aimed, the tip of the guidewire is lightly tapped into the bone before drilling to prevent the point from wandering. Alternatively, a pilot hole is created with a suitable bone awl.

The centre of the PL bundle is approximately located at the crossing point of two imaginary lines. The first is a vertical line (VL) through the contact point (CP) between thefemoralcondyleandthetibialplateauat90ºofkneeflexion. The second is the long axis of the ACL attachment site (AX). This crossing point is also about 5 to 8 mm anteriortotheedgeofthejointcartilage,adistancewhichcan be used when the ACL attachment footprint on the femur cannot be identified.

The guidewire is over-drilled with a 4.5 mm diameter cannulated drill. The length of the tunnel is measured with a depth gauge and the femoral component of the Hybrid PL graft completed.

TwosocketsarecreatedfortheAMbundle(typically35to40 mm deep) and PL bundle (typically 30 to 35 mm deep), with cannulated drills matched to the diameter of the two Hybrid grafts.

NOTE:Careshouldbetakentoensurethedrillsusedtocreatethesesocketsdonotbreachthelateralfemoralcortex, otherwise fixation with the button cannot be performed.

9 10 11

VL

AFS

PL Tunnel

5-8 mm

AM Tunnel

AX

CP

AM Tunnel(dia. 6-8 mm)

PL Tunnel(dia. 6 mm)

PL Tunnel(dia. 6 mm)

45˚

20˚

45˚

AM Tunnel(dia. 6-8 mm)20˚

4.5 mm pilot hole fo the AM Tunnel20˚

FixationA passing pin is used to pull the Hybrid graft for the PL bundle through the tibial tunnel and into the femoral tunnel. The button component is flipped on the femoral cortical surface. The graft for the AM bundle is then placed usingthesametechnique.

NOTE:Thekneeiscycledthroughafullrangeofmotionwhile examining the graft arthroscopically to ensure that it allows a full range of motion with no graft impingement on the lateral femoral condyle.

The thigh is manually fixed on a sterilized hard pillow placedontheoperatingtable.Theheeliskeptincontactwiththeoperatingtableandthekneeisflexedto10º.

NOTE: Graft tension in the PL and AM bundles is highest infullextension,sosuchakneepositionisrequiredforgraft tensioning and fixation to avoid post-operative graft failureasaresultofoverstretchingwhenthekneeisinextension1.

Before wound closureBone debris can accumulate in the lateral popliteal space and must be washed out through the medial portal.

IMPORTANT:• AnyloosefibrescreatedwhentrimmingthePoly-Tape

to length must be carefully removed from the incision site.

• AftertrimmingtolengthitmaybenecessarytorestrainthecutendsbystitchingthembacktothePoly-Tape.

A spring tensiometer is attached to the two ends of each Poly-Tape. A tension of 30 N is applied to each graft for 2 minutes using the tensiometer.

While under tension, the 2 ends of the Poly-Tapes are securedontotheAMaspectofthetibiausing2spikedstaples(notsupplied)intheturn-buckletechnique(Figure13a to c).

A Lachman test is performed, which should result in a negativeoutcometoconfirmastableknee.

Surplus Poly-Tape is cut with scissors at right angles to its length to minimize the generation of loose fibres (Figure 13d).

12 13 14

A B

C D

POST-OPERATIVE MANAGEMENTThe rehabilitation programme (below) provides only an outline of the prescribed regime. For a full description refer to the document entitled “Hybrid System, Rehabilitation for ACL repair”.

The rehabilitation programme should be supervised by a specialist physiotherapist. All mobilization and exercises should be performed within the pain free range of movement.

The patient should be warned not to exceed the prescribed activity levels or to overload the repair before complete healing has occurred.

The rehabilitation regime was developed in conjunction with Ian Horsley MSc, MCSP, Clinical Lead Physiotherapist, English Institute of Sport (EIS) North West, of BackinAction Physiotherapy and Sports Injury Clinic, Wakefield, UK.

Day 1 The leg is placed in a Continuous Passive Motion (CPM) machineandsubjectedtopassiveflexionofbetween20ºto 60º for as many hours as possible.

Day 2-7CPM between 20º and 90º flexion is continued but the range should be reduced to 20º to 60º if the patient complains of any pain.

Week 2Active Range of Motion (ROM), allowing flexion and extension, is initiated with the patient wearing a brace limiting the range of motion flexion/extension to 20º to 90º ofkneeflexion.

Week 3Continuewithweek2activities.Inaddition,passivefullextension is allowed twice per day as the patient tolerates. Partial weight-bearing is commenced with two handed support, e.g. crutches.

REFERENCES 1. Yasuda K, Kondo E, Ichiyama H, Tanabe Y, Tohyama H.

Surgical and biomechanical concepts of anatomic anterior cruciate ligament reconstruction. Oper Tech Orthop. 2005;15:96-102.

2. Kondo E, Yasuda K, Azuma H, Tanabe Y, Yagi T. Prospective clinical comparisons of anatomic double-bundle versus single-bundle anterior cruciate ligament reconstruction procedures in 328 consecutive patients. Am J Sports Med. 2008;36(9):1675-1687.

3. Yasuda K, Kondo E, Ichiyama H, Kitamura N, Tanabe Y, Tohyama H, Minami A. Anatomic reconstruction of the anteromedial and posterolateral bundles of the anterior cruciate ligament using hamstring tendon grafts. Arthroscopy. 2004;20(10):1015-1025.

4. Yamanaka M, Yasuda K, Tohyama H, Nakano H, Wada T. The effect of cyclic displacement on the biomechanical characteristics of anterior cruciate ligament reconstructions. Am J Sports Med. 1999;27(6):772-777.

5. Miyata K, Yasuda K, Kondo E, Nakano H, Kimura S, Hara N. Biomechanical comparisons of anterior cruciate ligament: reconstruction procedures with flexor tendon graft. J Orthop Sci. 2000;5:585-592.

6. Kondo E, Merican AM, Yasuda K, Amis AA. Biomechanicalcomparisonsofkneestabilityafteranteriorcruciate ligament reconstruction between 2 clinically available transtibial procedures. Am J Sports Med. 2010;38(7):1349-1358.

7. Yasuda K, Kondo E, Ichiyama H, Tanabe Y, Tohyama H. Clinical evaluation of anatomic double-bundle anterior cruciate ligament reconstruction procedure using hamstring tendon grafts: comparisons among 3 different procedures. Arthroscopy. 2006;22(3):240-251.

8. Miyatake S, Kondo E, Tohyama H, Kitamura N, Yasuda K. Biomechanical evaluation of a novel application of a fixation device for bone-tendon-bone graft (EndoButton CL BTB) to soft-tissue grafts in anatomic double-bundle anterior cruciate ligament reconstruction. Arthroscopy. 2010;26 (9):1226-1232.

9. Kondo E, Yasuda K. Second-lookarthroscopicevaluationsofanatomicdouble-bundle anterior cruciate ligament reconstruction: relation with postoperativekneestability.Arthroscopy. 2007;23(11):1198-209.

10. Kondo E, Yasuda K, Ichiyama H, Azuma C, Tohyama H. Radiological Evaluations of Femoral and Tibial Tunnels CreatedwiththeTrans-tibialTunnelTechniqueforAnatomicDouble-bundle Anterior Cruciate Ligament Reconstruction. Arthroscopy. 2007;23(8):869-876.

11. Yasuda K, Ichiyama H, Kondo E, Miyatake S, Inoue M, Tanabe Y. An in vivo biomechanical study on the tension-versus-kneeflexionanglecurvesof2graftsinanatomicdouble-bundle anterior cruciate ligament reconstruction: effects of initial tension and internal tibial rotation. Arthroscopy. 2008;24(3):276-284.

Weeks 4-5 ActiveROMexercise,withunblockedbrace,isallowedtothepatient’smaximumflexion/extensioncapability(thisis usually between 90º to 110º). Partial weightbearing is continued with one-handed support, e.g. a cane.

Weeks 6-10Limitation on both flexion and extension is no longer imposedbutwearinganunblockedbraceiscontinued.Full weight-bearing may be commenced at this stage. Extension training for muscles is begun, aiming at full development of ROM.

Weeks 10-12Lightsportsactivitiessuchasjoggingorswimmingmaybe commenced.

Weeks 12-24Gradual return to sporting activities is permitted. However, itmustbenotedthatthespeedofreturntofullpre-injurysporting activities should be governed by the state of themusclesoftheinjuredleg.Iftheyareinadequateitis recommended that the patient rehabilitates them to anadequatedegreebeforeengaginginanystrenuousactivitiesthatmightjeopardizethereconstructedligament.It should also be noted that, on the occurrence of any significant discomfort, it may be necessary to extend the rehabilitation programme accordingly.

Ordering Information

PleaserefertotheInstructionsforUseleafletpackedwiththePoly-Tape,LK2-HandFastlokforfurtheressentialinformationincludingUse,Sterility,Indications,Contraindications,Warningsand Precautions, Potential Adverse Effects and Storage. Additional copies may be obtained from Neoligaments™ sales department, or downloaded from http://www.neoligaments.com/doclib/

Hybrid System Implants for Anatomical Single and Double Tunnel repair, include:

102-1010 10 mm x 500 mm Poly-Tape (supplied sterile) (order 2 for double-tunnel repair)

Optional Tibial Fixation device for single tunnel repair: 102-1380 6mmx23mmFastlok(suppliedsterile)

Optional Femoral Fixation device: 102-1067 LK2-H,10mmx500mmPoly-TapewithSurfButton(suppliedsterile) (order 2 for double-tunnel repair)

PleasenotethattheLK2-HisnotavailableforsaleintheUSA

Fastlok Instruments

202-1137 Impactor/Extractor 202-1118 Sliding hammer

Neoligaments™ A division of Xiros™ Springfield House Whitehouse Lane LeedsLS197UE

Tel. +44 (0) 113 238 7202 Fax. +44 (0) 113 238 7201 enquiries@neoligaments.com www.neoligaments.com

Registered in England No. 1664824

All rights reserved. © Neoligaments™ 2011. Worldwide patents and patents pending. Neoligaments,HybridSystem,LK2-H, FastlokandXirosaretrademarksofXiros.

EndoButtonisatrademarkofSmithandNephew.

Developed and manufactured by

LAB 171 2.00